Endovascular Versus Open Repair of the Common Femoral Artery (TECCO)

Endovascular Versus Open Repair of the Common Femoral Artery: a Randomized Trial (TECCO)

Even though the indication for endovascular therapy has been enlarged, open repair of common femoral artery is still considered as the treatment of choice. A recent pilot study showed that endovascular repair of the CFA seems to be a safe technique of revascularization with acceptable initial results at 12 months (Azema et al, Eur J Vasc Endovasc Surg, 2011, in press). TECCO, a French randomized and controlled trial, has been set up to compare open and endovascular procedures for the treatment of CFA atherosclerotic lesions.

Study Overview

• Status: Completed
• Conditions: Atherosclerotic Lesions of the Common Femoral Artery
• Intervention / Treatment: Device: Endovascular treatment using self expandable nitinol STENTS; Device: Open repair treatment

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • University Hospital
  • Besançon, France
    • University Hospital
  • Bordeaux, France
    • University Hospital
  • Clermont-Ferrand, France
    • University Hospital
  • Dijon, France
    • University Hospital
  • Lyon, France
    • University Hospital
  • Marseille, France
    • University Hospital
  • Nantes, France
    • University Hospital
  • Nantes, France
    • NCN Clinic
  • Nantes, France
    • St Augustin Clinic
  • Nice, France
    • University Hospital
  • Paris, France
    • University Hospital, HEGP
  • Paris, France
    • University Hospital, Henri Mondor
  • Rouen, France
    • University Hospital
  • St Etienne, France
    • University Hospital
  • Strasbourg, France
    • University Hospital
  • Villeurbanne, France
    • Tonkin Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 40 and 90 years-old
• De novo atheromatous common femoral artery stenosis
• Symptomatic lesions (Rutherford stages 3, 4, 5 and 6)
• Haemodynamically significant lesion
• Written informed consent

Exclusion Criteria:

• Restenosis
• Non-atheromatous lesions (dysplasia, post-traumatic, inflammatory)
• external iliac thrombosis and / or common femoral side to treat
• Contraindication to open surgery or endovascular treatment
• Contraindication to anesthesia
• Indication of aorto-femoral, ilio-femoral, femoral-popliteal or femoro-tibialis bypass to associate with the common femoral revascularization
• Indication of a surgical approach to the external iliac artery through a retroperitoneal
• Asymptomatic lesions
• Life expectancy less than one year
• Refusing patient
• Inability to monitor during the test period
• Participation in another clinical trial
• Pregnant Women
• No written informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endovascular treatment	Device: Endovascular treatment using self expandable nitinol STENTS; A direct stenting will be performed.
Active Comparator: Open repair treatment	Device: Open repair treatment; The surgeon will perform its usual technique to revascularize the common femoral artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbid-mortality rate at 30 days	Morbid-mortality rate is defined by: Death, general complications and local complications requiring re-admission and / or reoperation.	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Target lesion revascularization	6 months
Target lesion revascularization	12 months
Technical success	1 month
Hospital length of stay	1 month
Primary sustained clinical improvement	1 month
Primary sustained clinical improvement	6 months
Primary sustained clinical improvement	12 months
Primary sustained clinical improvement	24 months
Target lesion revascularization	1 month
Target lesion revascularization	24 months
In-stent restenosis	1 month
In-stent restenosis	6 months
In-stent restenosis	12 months
In-stent restenosis	24 months
Stent fracture	1 month
Stent fracture	6 months
Stent fracture	12 months
Stent fracture	24 months
Secondary sustained clinical improvement	1 month
Secondary sustained clinical improvement	6 months
Secondary sustained clinical improvement	12 months
Secondary sustained clinical improvement	24 months
Target extremity revascularization	1 month
Target extremity revascularization	6 months
Target extremity revascularization	12 months
Target extremity revascularization	24 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Yann GOUEFFIC, Doctor, Nantes University Hospital

Publications and helpful links

General Publications

• Goueffic Y, Della Schiava N, Thaveau F, Rosset E, Favre JP, Salomon du Mont L, Alsac JM, Hassen-Khodja R, Reix T, Allaire E, Ducasse E, Soler R, Guyomarc'h B, Nasr B. Stenting or Surgery for De Novo Common Femoral Artery Stenosis. JACC Cardiovasc Interv. 2017 Jul 10;10(13):1344-1354. doi: 10.1016/j.jcin.2017.03.046.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: May 9, 2011
• First Submitted That Met QC Criteria: May 11, 2011
• First Posted (Estimate): May 13, 2011

Study Record Updates

• Last Update Posted (Estimate): December 23, 2015
• Last Update Submitted That Met QC Criteria: December 22, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 10/6-Q